# K200770: Mini PCNL-System

- Pathway: 510(k) (Traditional)
- Applicant: Trokamed GmbH
- Decided: Jul 30, 2021 after 492 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K770729 (1977). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994223: Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree, Straight View; Nephroscope, 20, Richard Wolf Medical Instruments Corp. (2000) Summary page 5.

## Recalls of this device
- Nov 27, 2024 · Class I · Z-0715-2025: If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
- Nov 27, 2024 · Class I · Z-0713-2025: If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
- Nov 27, 2024 · Class I · Z-0714-2025: If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
- Nov 27, 2024 · Class I · Z-0716-2025: If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

## Indications for use
The nephroscopy accessory set is intended for minimally invasive procedures in nephroscopy. The shaft is a reusable, surgically invasive device for shortterm use. It is designed to bring instruments, telescopes, and fluids to the surgical site. The Dilator is a reusable, surgically invasive device for temporary use. It is designed to widen existing surgically invasive openings.

Source page: https://510kreport.com/device/K200770
Methodology: https://510kreport.com/methodology